Cleared Abbreviated

K041717 - POWERSTICK MALE LATEX CONDOMS

K041717 is an FDA 510(k) clearance for POWERSTICK MALE LATEX CONDOMS, manufactured by A.P.Deauville, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 203-day FDA review.

K041717 · A.P.Deauville, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
203d
Days
Class 2
Risk

K041717 is an FDA 510(k) clearance for the POWERSTICK MALE LATEX CONDOMS. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by A.P.Deauville, LLC (New Brunswick, US). The FDA issued a Cleared decision on January 13, 2005 after a review of 203 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K041717

510(k) Number K041717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2004
Decision Date January 13, 2005
Days to Decision 203 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 161d · This submission: 203d
Pathway characteristics
Standards-based clearance path.

HIS Device Classification - Class 2, Special Controls

Product Code HIS Condom
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIS Condom

All 396
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K041717.
TULIP CONDOM
K050360 · Shanghai Latex Factory · Mar 2005
DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT
K042957 · Ssl Americas · Feb 2005
SAN-MAR LABS LUBRICATING JELLY
K041667 · San-Mar Laboratories, Inc. · Jan 2005
ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT
K041432 · Biofilm, Inc. · Nov 2004
INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED
K041837 · Innolatex Sdn. Bhd · Sep 2004
DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM
K040185 · Ssl Americas · Apr 2004
K041717 · POWERSTICK MALE LATEX CONDOMS
Download PDF FDA Summary A.P.Deauville, LLC